New Conservative Technique for Placenta Accreta Spectrum

Overview

participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery. Investigators manually detected a plan of cleavage through which the placenta was separated followed by closure of defective placental bed. Data were collected about the outcome.

Full Title of Study: “Placenta Accreta; A Vision for Conservative Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 20, 2020

Detailed Description

Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to help sure diagnosis of PAS. Cesarean section will be performed through extended transverse supra-pubic incision bladder dissection from anterior uterine wall using electro-coagulation instruments and double ligation of large caliber bridging vessels. Uterine incision above the placental bulge by at least 5 mm then complete separation of the placenta starting from least resistance plans to high resistant one leaving a clear defect which will be closed by running sutures from inside the uterus and controlling placental bed hemorrhage then closing the uterine incision with compressing the bed from outwards ( double compression sutures ) internal Iliac artery ligation may be done as a complementary measure to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain and closure of abdominal wall in layers.

Interventions

  • Diagnostic Test: ultrasound
    • trans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode
  • Procedure: closure of uterine wall defect
    • uterine incision above placental bulge by at least 5 mm then complete separation of the placenta starting from areas of least resistance to areas of high resistance leaving a clear defect which will be closed by non locked running sutures from inside the uterus starting from one edge, hitch the bed to the other edge of the defect and controlling placental bed hemorrhage then closing the uterine incision via running sutures in 2 layers with compressing the bed from outwards in the first layer. hemostasis of the abnormal pelvic vasculature if excessive bleeding internal iliac artery may be ligated then insertion of intra-peritoneal drain followed by closing the abdomen.

Arms, Groups and Cohorts

  • Experimental: pregnant women with placenta accreta spectrum
    • The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.

Clinical Trial Outcome Measures

Primary Measures

  • surgical outcome
    • Time Frame: from the time of the surgery until 48 hours after.
    • number of participants whom their uterus were preserved without major hemorrhage
  • intra-operative blood loss
    • Time Frame: intraoperative
    • the amount of blood loss during operation was estimated for each participant.
  • surgical complications
    • Time Frame: intraoperative
    • number of participants had bladder, ureter injury or hysterectomy,
  • internal iliac artery ligation
    • Time Frame: intra-operative
    • number of participants had with either unilateral or bilateral internal iliac artery ligation
  • high dependency unit admission
    • Time Frame: from 0 to 48 hours postoperative
    • number of participants needed high dependency unit admission
  • wound complications
    • Time Frame: up to 2 weeks postoperative
    • number of patients suffered wound infection
  • change in the hemoglobin level
    • Time Frame: from 48 hours pre operative to 48 hours post operative
    • participant’s hemoglobin was measured
  • blood transfusion
    • Time Frame: from 48 hours preoperative to 48 hours postoperative.
    • number of units of blood and it’s products transfused to participants
  • hematuria
    • Time Frame: post-operative up to 24 hours
    • number of participants suffered hematuria
  • manual cervical assesment
    • Time Frame: before skin incision
    • participants were subjected to vaginal examination to asses the cervix lenght
  • placental separation
    • Time Frame: intra-operative
    • number of participants whom their placenta was separated manually
  • surgical grading of the placenta
    • Time Frame: intra-operative
    • number of participants who had accreta, increta, percreta or mixed type
  • ultrasound grading of the placenta
    • Time Frame: pre-operative
    • number of participants who were diagnosed by ultrasound as accreta, increta or percreta
  • manual assessment of vaginal fornices
    • Time Frame: before skin incision
    • participants were subjected to vaginal examination to asses fornices

Secondary Measures

  • placental bed
    • Time Frame: intra-operative
    • number of participants that investigators detected a well delineated placental bed like a pouch

Participating in This Clinical Trial

Inclusion Criteria

  • pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section, with or without other uterine surgeries and less than 40 years of age. Exclusion Criteria:

  • pregnant women having medical conditions such as cardiac diseases, coagulopathy and hematological disorders. pregnant women had 5 or more previous Cesarean sections or their age more than 40 years

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alexandria University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mahmoud A Hamdy, principal investigator – Alexandria University
  • Overall Official(s)
    • Mahmoud AH Hamdy, A. lecturer, Principal Investigator, faculty of medicine department of obstetrics and gyneacology

Citations Reporting on Results

Sentilhes L, Kayem G, Chandraharan E, Palacios-Jaraquemada J, Jauniaux E; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Conservative management. Int J Gynaecol Obstet. 2018 Mar;140(3):291-298. doi: 10.1002/ijgo.12410.

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